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Amino acid and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)

by Bgi Europe a/S Denmark EUDAMED

Ref MFG030024; MFG030025Model 96, 960T

EMDN W01010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05744003510061 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Amino acid and Carnitine Detection Kit (Liquid Chromatography-Tandem Mass Spectrometry)
Model / Reference
96, 960T, MFG030024, MFG030025
Primary DI / UDI-DI
05744003510061
Basic UDI-DI
B-05744003510061
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f401ab7b-c11f-44ef-a003-82e5a15958ef-1 61 fields · synced 22 Oct 2026